NCT02964949

Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

Evaluation of Edoxaban in Anticoagulant Naïve Patients With Nonvalvular Atrial Fibrillation (NVAF) and High Creatinine Clearance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart. This can lead to blood clots forming in the heart chamber. Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for up to 12 months, with a 2-4 week follow-up, after which their participation is complete. Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30, 90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Edoxaban	Edoxaban will be provided in blister packs with active and placebo tablets maintaining the blind, i.e., one 60 mg active tablet and a 15 mg placebo or one 60 mg active tablet and a 15 mg active tablet. Transition doses of 30 mg + 15 mg edoxaban are provided in 14-tablet blister packs.

Timeline

• Start date: 2017-01-24
• Primary completion: 2018-10-09
• Completion: 2018-10-09
• First posted: 2016-11-16
• Last updated: 2019-02-12

Locations

233 sites across 15 countries: Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, Hungary, Latvia, Lithuania, Poland, Russia, Serbia, Slovakia, Spain, Ukraine